Ultra-sound catheter for removing obstructions from tubular anatomical structures such as blood vessels

ABSTRACT

An ultrasound catheter for removing obstructions from tubular anatomic structures such as blood vessels, said catheter comprising an elongate flexible catheter body having an ultrasound transmission member or wire extending longitudinally therethrough. A distal head is formed on the distal end of the ultrasound transmission member or wire and is affixed to the catheter body. The ultrasound transmission member or wire may be formed of any material capable of transmitting ultrasonic energy including various superelastic metal alloys such as nickel titanium metal alloys. The distal portion of the ultrasound transmission member or wire may be of reduced diameter to provide enhanced flexibility and/or amplification of the ultrasonic energy through the distal portion of the ultrasound transmission member or wire. A proximal end connector may be provided with a sonic connector to effectively couple the catheter to the ultrasound transducer.

This application is a continuation-in-part of U.S. application Ser. No.07/878,795, filed on May 5, 1992, now U.S. Pat. No. 5,267,954 which is acontinuation-in-part of U.S. application Ser. No. 07/787,292, filed Nov.4, 1991 abandoned, which is a continuation-in-part of U.S. applicationSer. No. 07/640,190, filed Jan. 11, 1991 now U.S. Pat. No. 5,304,115.

FIELD OF THE INVENTION

The present invention pertains to medical equipment and moreparticularly an ultrasonic catheter for ablating obstructions withintubular anatomical structures such as blood vessels.

BACKGROUND OF THE INVENTION

A number of ultrasonic devices have heretofore been proposed for use inablating or removing obstructive material from blood vessels. Examplesof ultrasonic ablation devices in related apparatus purported to beuseable in removing obstructions from blood vessels include thosedescribed in U.S. Pat. Nos. 3,433,226 (Boyd), 3,823,717 (Pohlman, etal.), 4,808,153 (Parisi), 4,936,281 (Stasz), 3,565,062 (Kuris),4,924,863 (Sterzer), 4,870,953 (Don Michael, et al., and 4,920,954(Alliger, et al.), as well as other patent publications WO87-05739(Cooper), WO89-06515 (Bernstein, et al.), WO90-0130 (Sonic Needle Corp.), EP316789 (Don Michael, et al.), DE3,821,836 (Schubert) andDE2,438,648 (Pohlman).

Ultrasound transmitting catheters have been utilized to successfullyablate various types of obstructions from blood vessels of humans andanimals. Particular success has been observed in ablation ofatherosclerotic plaque or thromboembolic obstructions from peripheralblood vessels such as the femoral arteries. Successful applications ofultrasonic energy to smaller blood vessels, such as the coronaryarteries, necessitates the use of ultrasound transmitting catheterswhich are sufficiently small and flexible to permit transluminaladvancement of such catheter through the tortuous vasculature of theaortic arch and coronary tree. Accordingly, the safety and efficacy ofremoving obstructions from coronary arteries by way of ultrasound islargely dependent upon the size and flexibility of the ultrasoundtransmitting catheter(s) employed.

Thus, there exists a need in the art for improved ultrasound catheterswhich are sufficiently flexible to be advanced and inserted into bothsmall tortuous blood vessels, such as the coronaries arteries.

SUMMARY OF THE INVENTION

In accordance with the invention, there is provided an ultrasoundcatheter device comprising an elongate flexible catheter body having atleast one lumen extending longitudinally therethrough. An elongateultrasound transmission member extends through the catheter body and isconnected, at its distal end, to a distal head. The entire distal head,or a portion thereof, may protrude out of and beyond the distal end ofthe catheter body. The distal head is secured or affixed to the catheterbody.

Further in accordance with the invention, there is provided anultrasound catheter having an elongate ultrasound transmission memberextending longitudinally therethrough, said ultrasound transmissionmember being formed of one or more superelastic materials, such ascertain superelastic metal alloys, which exhibit superelastic propertieswithin the range of temperatures undergone by the ultrasoundtransmission member during operation of the device. Still further inaccordance with the invention, there is provided an ultrasound catheterhaving an elongate ultrasound transmission member extendinglongitudinally therethrough, said elongate ultrasound transmissionmember having a proximal portion of a first cross-sectional dimension ordiameter and a distal portion of a second cross-sectional dimension ordiameter less than said first cross-sectional dimension or diameter.Such lessening of the cross-sectional dimension or diameter of thedistal portion of the ultrasound transmission member results in moreflexibility and less rigidity of the ultrasound transmission memberwithin such region thereof. Additionally, such lessening of thecross-sectional dimension or diameter of the distal portion of theultrasound transmission member results in an amplification of ultrasoundtransmitted through such transmission member.

Still further in accordance with the invention, there is provided anultrasound transmission catheter having an elongate ultrasoundtransmission member extending therethrough and a guidewire passage lumenextending longitudinally through the catheter to permit the catheter tobe utilized in accordance with over-the-wire (OTW) insertion techniques.

Still further in accordance with the invention, there is provided anultrasound transmission catheter having an elongate ultrasoundtransmitting member extending longitudinally therethrough and aguidewire guide or member extending laterally outboard of the catheterin at least one position thereon. Such guidewire guide or support memberis provided with at least one guidewire passage aperture extendinglongitudinally therethrough to permit a guidewire to be passedtherethrough, thereby permitting the ultrasound catheter to be utilizedin accordance with monorail guidewire insertion techniques.

Still further in accordance with the invention, there is provided anultrasound transmission catheter having an elongate ultrasoundtransmitting member extending longitudinally therethrough and a distalguidewire lumen extending longitudinally through only a distal portionof the catheter. Such distal guidewire passage lumen comprises anelongate tube or passageway having a distal end and a proximal end. Thedistal end of the elongate tube or passageway opens through a distal endaperture and the proximal end of the elongate tube or passageway opensthrough a guidewire entry/re-entry aperture formed at a point in thesidewall of the catheter. Accordingly, a guidewire may be proximally ordistally advanced through said distal guidewire lumen within the distalportion of the catheter body while a remaining proximal portion of theguidewire resides outside of and next to the catheter body.

Still further in accordance with the invention, there are providedproximal end connector assemblies which operate to connect the proximalend of an ultrasound transmission catheter to an ultrasound transducer.The proximal end connector assemblies of the present invention comprisegenerally tubular members having at least one longitudinal bore throughwhich the ultrasound transmission member of the catheter may extend andat least one connector apparatus for connecting the ultrasoundtransmission member to an attendant ultrasound transducer. In oneembodiment, the sonic connector comprises a compressible grippingferrule which may be tightened to grip and firmly hold the ultrasoundtransmission member in place to provide a damping effect to preventundesirable transverse movement. In a second embodiment, the sonicconnector comprises a plurality of compressible plugs which are alsotightened to grip and firmly hold the ultrasound transmission member toachieve the required damping effect, as well as to secure the ultrasoundtransmission member to the sonic connector. In a third embodiment, thesonic connector comprises both a plurality of compressible plugs and agripping ferrule. In other further embodiments, a polymeric coating maybe applied to the various connections between the ultrasoundtransmission member and the sonic connector, either in conjunction withthe gripping ferrule and/or the compressible plugs or independent of theferrule and plugs, to secure these connections.

The proximal end connector assemblies of the present invention may beprovided with one or more fluid infusion sidearms for infusing coolantliquid or other fluid through the bore of the proximal connector andthrough a lumen of the catheter body. Additionally, in some embodiments,a guidewire passage sidearm may be positioned on the proximal connectorassembly to permit insertion and/or extraction of a guidewire throughthe proximal connector assembly and through the body of the catheter.One or more guidewire diverting members, such as an angled tubularmember, may be positioned within the proximal connector assembly todivert a proximally advancing guidewire out of a guidewire sidearmpositioned thereon.

Still further in accordance with the invention, there is provided anultrasound catheter having an elongate ultrasound transmission memberextending longitudinally therethrough, said ultrasound transmissionmember having a friction-reducing coating or outer jacket formedthereon. Such friction reducing coating or outer jacket may comprise alayer of low friction polymeric material such as polytetrafluoroethylene(ptfe) (teflon™ Dupont, Inc., Wilmington, Delaware) or polyethylene.Such friction reducing coating or jacket may be disposed over the entireouter surface of the ultrasound transmission member or may be confinedto a specific region or regions thereof.

Further objects and aspects of the invention will become apparent tothose skilled in the art upon reading and understanding the followingdetailed description and the accompanying drawings.

BRIEF DESCRIPTIONS OF THE DRAWINGS

FIG. 1 is a perspective view of a first embodiment of an over-the-wireultrasound catheter of the present invention.

FIG. 2 is partial enlarged perspective view of the distal end of a firstembodiment of an over-the-wire ultrasound catheter of the presentinvention.

FIG. 2a is a partial cut-away perspective view of an ultrasoundtransmission member positionable in an ultrasound catheter and having afriction reducing coating or jacket disposed thereon.

FIG. 3 is a longitudinal sectional view through Line 3-3 of FIG. 2.

FIG. 4 is an enlarged perspective view of the distal portion of anembodiment of a monorail ultrasound catheter of the present invention.

FIG. 5 is a perspective view of the distal portion of an embodiment ofan ultrasound catheter of the present invention having a region ofenlarged diameter and a partial guidewire lumen running through a distalportion of the catheter body.

FIG. 5a is a perspective view of the distal portion of an embodiment ofan ultrasound catheter of the present invention having a partialguidewire lumen running through a distal portion of the catheter body.

FIG. 6 is a longitudinal sectional view of the embodiment of theultrasound catheter shown in FIG. 5.

FIG. 6a is an exploded view of a distal tip of the ultrasound catheterembodiments shown in FIGS. 5 and 5a.

FIG. 6b is an enlarged view of the distal end of the longitudinalsectional view of FIG. 6.

FIG. 7 is a perspective view of a proximal end connector end apparatuspositionable on the proximal end of an ultrasound catheter of thepresent invention for connecting the catheter to an ultrasoundtransducer.

FIG. 8 is a perspective view of an alternative proximal end connectorassembly positionable on the proximal end of an ultrasound catheterhaving an internal guidewire lumen for attaching the ultrasound catheterto an ultrasound transducer.

FIG. 9 is a longitudinal sectional view of the proximal end connectorassembly shown in FIG. 5.

FIG. 10 is a perspective view of the guidewire diverter apparatus and afirst embodiment of a sonic connector positioned within the proximal endconnector assembly shown in FIGS. 5 and 6.

FIG. 11 is an enlarged perspective view of a second embodiment of asonic connector positioned within the proximal end connector assembly ofFIG. 10.

FIG. 12 is a cross-sectional view of the sonic connector of FIG. 11taken along Line 12--12 in FIG. 11.

FIG. 13 is an enlarged perspective view of a third embodiment of a sonicconnector positioned within the proximal end connector assembly of FIG.10.

FIG. 14 is an enlarged perspective view of a fourth embodiment of asonic connector positioned within the proximal end connector assembly ofFIG. 10.

FIG. 15 is an enlarged perspective view of a fifth embodiment of a sonicconnector positioned within the proximal end connector assembly of FIG.10.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The following detailed description in the accompanying drawings areprovided for purposes of illustrating and describing specificembodiments of the present invention and are not intended to limit thescope of the present invention in any way.

The ultrasound catheters of the present invention include both"over-the-wire" configurations and "monorail" configuration. As usedherein, the term "over-the-wire" shall refer to an ultrasound catheterwhich has a guidewire passage lumen formed within the body of thecatheter such that a flexible guidewire may be advanced through the bodyof the catheter and out of a guidewire passage aperture formed in thedistal end of the catheter. As used herein, the term "monorail" shallrefer to an ultrasound catheter which has a guidewire supportingstructure at or near the distal tip of the catheter and extendinglaterally outboard of the outer surface of the catheter body such that aflexible guidewire may reside next to the catheter body with the distalend of such guidewire extending through and/or being held by theguidewire supporting structure formed on or near the distal end of thecatheter body.

FIG. 1 is a perspective showing of an over-the-wire ultrasound catheter10 of the present invention having a proximal end connector assembly 12mounted on the proximal end thereof. An ultrasound transducer 14 isconnected to the proximal end of the proximal connector assembly 12. Anultrasound generator 16 having a foot actuated on/off switch 18 isoperatively connected to the ultrasound generator 14 so as to sendultrasonic energy through the ultrasound catheter 10, when desired.

One embodiment of an over-the-wire ultrasound catheter 10 of the presentinvention are shown in FIGS. 2 and 3. As shown, one embodiment of anover-the-wire ultrasound catheter 10 of the present invention comprisesa flexible tubular catheter body 20 having a hollow lumen 22 extendinglongitudinally therethrough. This over-the-wire catheter body preferablyhas an outside diameter of 0.5 mm-5.0 mm. In catheters 10 intended forinsertion into tortuous or relatively small anatomical structures (e.g.,the coronary arteries) it is preferable that the outer diameter of thecatheter body 20 be 0.25 mm-2.5 min.

One embodiment of a monorail ultrasound catheter 10a of the presentinvention are shown in FIG. 4. As shown, a monorail ultrasound catheter10a of the present invention comprises a flexible tubular catheter body20a having a hollow lumen 22a extending longitudinally therethrough. Aswith the over-the-wire catheter 10, it is preferable that the outsidediameter of the catheter body 20a of the monorail catheter 10a be 0.5mm-5.0 mm. In monorail catheters 10a intended for use in tortuous orrelatively small anatomical structures (e.g., the coronary arteries) itis preferable that the outer diameter of the catheter body be 0.25mm-2.0 mm and it is further specifically preferable that the width ofthe distal head 26a be, at its widest point, no greater than 3.0 mm suchthat the entire distal head 26a and the catheter body 20a may beinserted into an anatomical passageway of approximately 3.0 mm diameter,(e.g. the coronary artery).

In both the "over-the-wire" and "monorail" embodiments of the invention,an ultrasound transmission member 24 or wave guide extendslongitudinally through the lumen 22 of the catheter body 20 to transmitultrasonic energy from an ultrasound transducer 14 connected to theproximal end of the catheter 10 to the distal end thereof. Preferably adistal head 26 is mounted on the distal end of the ultrasoundtransmission member 24. In the embodiments shown, the distal head 26comprises generally round, conical, or disc-shaped distal portion 28 anda reduced diameter neck or proximal portion 30. The outer diameter OD ofthe proximal portion 30 of the distal head 26 is approximately the sameas or slightly less than the inner diameter ID of the catheter lumen 22such that the proximal portion 30 of the distal head 26 may be insertedinto the distal end of the lumen 22, to a point where the distal tip ofthe catheter body 20 abuts against the proximal aspect of the distalportion 28 of the distal head 26, as shown.

The ultrasound transmission member 24 may be formed of any materialcapable of effectively transmitting the ultrasonic energy from theultrasound transducer 14 to the distal end of the catheter body 20,including but not necessary limited to metal, plastic, hard rubber,ceramic and/or composites thereof.

In accordance with one aspect of the invention, all or a portion of theultrasound transmission member 24 may be formed of one or more materialswhich exhibit superelasticity. Such material(s) should preferablyexhibit superelasticity consistently within the range of temperaturesnormally encountered by the ultrasound transmission member 24 duringoperation of the device 10.

Specifically, all or part of the ultrasound transmission member 24 maybe formed of one or more metal alloys known as "shape memory alloys".

Examples of super elastic metal alloys which are usable to form theultrasound transmission member 24 of the present invention are describedin detail in U.S. Pat. Nos. 4,665,906 (Jervis); 4,565,589 (Harrison);4,505,767 (Quin); and 4,337,090 (Harrison). The disclosures of U.S. Pat.Nos. 4,665,906; 4,565,589; 4,505,767; and 4,337,090 are expresslyincorporated herein by reference insofar as they describe thecompositions properties, chemistries and behavior of specific metalalloys which are superelastic within the temperature range at which theultrasound transmission member of the present invention operates, anyand all of which superelastic metal alloys may be usable to form thesuperelastic ultrasound transmission member 24 of the present invention.

In particular, one presently preferred superelastic metal alloy of whichthe ultrasound transmission member 24 may be formed is a nickel-titaniumalloy wire made up of 55.8 weight percent nickel (NiTi containing 55.8%weight % Ni balance Ti). Such material is commercially available asTinel™ Wire from Raychem Corporation, Menlo Park, Calif.

In any embodiment of the device, the ultrasound transmission member 24may be tapered, narrowed or otherwise reduced in cross-sectionaldimension within a distal portion of the catheter so as to decrease therigidity of the ultrasound transmission member 24 within such distalportion of the device and also to cause amplification of the ultrasoundtransmitted to the distal head 26. As shown in FIG. 6, such tapering ornarrowing of the ultrasound transmission member divides the ultrasoundtransmission member into a proximal portion 24p and a distal portion24d. An angular tapered or narrowing region 154 embodies the transitionzone between the larger proximal portion 24p and the smaller distalportion 24d. Because the distal portion 24d of the ultrasoundtransmission member is of smaller cross-sectional diameter and lessmass, it is more flexible and less rigid than the proximal portion 24pthereof. Such configuration of the ultrasound member 24 enables therelatively large sized proximal portion 24p to transmit more ultrasonicenergy than if the entire length of the ultrasound transmission member24 were to be of the relatively small cross-sectional size of the distalportion 24d thereof. Additionally, such decrease in the cross-sectionalsize of the distal portion 24d of the ultrasound transmission member 24results in an amplification of the ultrasound transmitted through suchdistal portion 24d thereof. Thus, by limiting the reduced size portionof the ultrasound transmission member 24 to a discrete region thereofnear the distal tip of the catheter, the proximal portion 24p of theultrasound transmission member is rendered capable of transmitting agreater amount of ultrasonic energy to the distal end of the catheterthan would otherwise be possible, while the reduced cross-sectional sizeof the distal portion of the ultrasound transmission member 24additionally serves to amplify the ultrasound reaching the distal head26 of the device.

In embodiments of the device wherein an enlarged region 152 is formed onthe catheter body 20b, it is desirable that the taper 154 of theultrasound transmission member 24b be positioned at the distal end ofthe bulge or enlarged region 152 so as to result in that portion of thecatheter lying distal to the distal end of the enlarged region 152 beingmore flexible and less rigid than the remainder of said catheter, due tothe decreased diameter of the ultrasound transmission member 24dextending through such portion.

In embodiments of the device wherein the cross-sectional dimension orouter diameter of the catheter body is substantially constant (i.e.,FIG. 5a) the tapered region 154 of the ultrasound transmission member 24may be formed at any point desired such that portion of the catheterlying distal to the tapered region 154 will, as a result, exhibit lessrigidity and greater flexibility than the remainder of the catheterbody.

The present invention further includes an optional improvement to theultrasound transmission member 24 of any ultrasound transmittingcatheter, said improvement comprising the disposition of a low frictioncoating or jacket 25 on the outer surface of all or a portion of theultrasound transmission member 24. As shown in FIG. 2a, the low frictioncoating or jacket 25 may be disposed on the outer surface of theultrasound transmission member 24 so as to completely cover theultrasound transmission member 24 along its entire length, or along adiscrete region or regions thereof. Such coating or jacket 25 maycomprise a layer of low friction polymer material such aspolytetrafluoroethylene (ptfe) (teflon™ Dupont, Inc., Wilmington, Del.)or other plastic materials such as polyethylene. The coating or jacket25 may be applied as a liquid and subsequently allowed to cure or hardenon the surface of the ultrasound transmission member 24. Alternatively,the coating jacket 25 may be in the form of an elongate tube slideablydisposable over the outer surface of the ultrasound transmission member24. Such coating or jacket 25 serves to prevent or diminish frictionbetween the outer surface of the ultrasound transmission member 24 andthe adjacent structures of the catheter 10 or proximal end connectorassembly 12 through which the ultrasound transmission member 24 extends.

The distal head 26 is firmly bonded, attached, or connected to thecatheter body 20 such that the distal head is prevented from undergoinglongitudinal or transverse movement separate from or relative to thecatheter body. Such non-moveable affixation of the distal head 26 to thecatheter body prevents longitudinal or transverse movement of the distalhead 26 apart from the catheter body 20. Additionally, such affixationof the distal head to the catheter body increases the conveyance ofultrasound energy into the distal portion of the catheter body 20,thereby resulting in enhanced cavitation effects created by the distalportion of the catheter body. Such bonding connection or attachment ofthe distal head 26 to the catheter body 20 may be accomplished by anysuitable means. One means of attaching the distal head 26 to thecatheter body 20 is through the use of adhesive 32.

In the embodiments shown in FIGS. 2-4, the adhesive 32 is applied to theproximal portion 30 of the distal head 26 prior to insertion thereofinto the distal end of the lumen 22 of the catheter body 20. Theadhesive 32 may comprise any suitable adhesive, such as cyanoacrylate(e.g. Loctite™, Loctite Corp., Ontario, CANADA or Dron Alpha™, Borden,Inc., Columbus, Ohio) or polyurethane (e.g. Dymax™, Dymax EngineeringAdhesive, Torrington, CT.) to firmly bond and attach the distal head 26to the catheter body 20. The distal head 26 may be formed of anysuitable rigid material such as metal or plastic. In devices wherein thedistal head is formed of plastic, the surrounding plastic catheter body20 may be thoroughly welded, heat sealed or solvent welded to theplastic distal head 26, in accordance with the types of plasticsemployed.

In the alternative to the use of adhesives, various mechanical orfrictional connectors, such as screw threads, lugs or other surfacemodifications formed on the proximal portion 30 of the distal head 26,may be utilized to hold the distal head 26 in a fixed position relativeto the catheter body 20. In such embodiments, corresponding grooves,detents or surface modifications may also be formed in the surroundinginner wall of the catheter body 20 so as to cooperate with any suchthreads, lugs or other surface modifications formed on the opposingsurface of the distal head 26. Such threads, lugs or other surfacemodifications will be configured and constructed so as to mechanicallyor frictionally hold the distal head 26 in fixed position relative tothe catheter body 20.

The distal head 26 is preferably formed of radiodense material so as tobe easily discernable by radiographic means. Accordingly, the distalhead 26 may preferably be formed of metal or, alternatively, may beformed of plastic, ceramic or rubber materials, optionally having one ormore radiodense markers affixed thereto or formed therein. For example,the distal head 26 may be molded of plastic such asacrylonitrile-butadiene-styrene (ABS) and one or more metallic foilstrips or other radio opaque markers may be affixed to such plasticdistal head 26 in order to impart sufficient radiodensity to permit thedistal head 26 to be readily located by radiographic means.Additionally, in embodiments wherein the distal head 26 is formed ofmolded plastic or other non-metallic material, a quantity of radiodensefiller such as powdered bismuth or BaSO₄ may be disposed within theplastic or other non-metallic material of which the distal head 26 isformed so as to impart enhanced radiodensity to the distal head 26.

An optional guidewire passage aperture 40 may extend longitudinallythrough the distal head 26. Such guidewire passage aperture 40 may beformed through the distal head at a location inboard of the catheterbody 20 such that a guidewire 42 may be advanced through a lumen 22 ofthe catheter body and through guidewire passage aperture 40. Suchembodiments of the ultrasound catheter 10 wherein the guidewire 42passes through a lumen formed within the catheter body 20 and out of thecatheter passage aperture 40 constitute an "over-the-wire" embodiment ofthe invention.

Alternatively, the distal head 26a may be formed such that a portion ofthe distal head extends laterally outboard of the outer surface of thecatheter body 20a and the guidewire passage aperture 40a may be,likewise, positioned outboard of the outer surface of the catheter body20a thereby forming a guidewire alongside the catheter body 20a andthrough the guidewire passage aperture 40a. Such embodiments of theinvention wherein the guidewire 42a is passed outboard of the outersurface of the catheter body 20a and through the catheter passageaperture 40a are referred to sometimes herein as "monorail" embodiments.

In addition to the over-the-wire embodiment (FIG. 2) and the "monorail"embodiment (FIG. 4) the ultrasound catheter of the present invention mayalso be formed in embodiments which constitute combinations or hybridsof such over-the-wire and monorail embodiments, as shown in FIGS. 5, 5aand 6. Specifically, such embodiments of the invention comprise anultrasound catheter having a guidewire passage lumen formed through adistal portion of the catheter body only, with a guidewireentry/re-entry aperture 160 being formed through a sidewall of thecatheter to permit passage of the guidewire 42 from the distal guidewirelumen of the catheter to a position outside the catheter body.

As shown in FIGS. 5, 5a and 6, the catheter body 20b may be providedwith a distal guidewire passage tube 156 positioned within the innerbore or lumen 22b of the catheter body 20b and extending from aguidewire re-entry aperture 160 to the guidewire passage aperture 40bformed in the distal head 26b of the device. As such, the proximal endof a pre-inserted guidewire may be inserted into the distal end of thecatheter body 20b through guidewire passage aperture 40b andsubsequently advanced in a proximal direction through the guidewirelumen 158 to a point where the proximal end of the guidewire 42 emergesout of guidewire entry/re-entry aperture 160. After emerging fromguidewire entry/re-entry aperture 160, the proximal portion of theguidewire 42 may extend and/or reside adjacent the outer surface of theproximal portion of the catheter body 20b as shown. The catheter body20b and the guidewire 42 may then be distally and/or proximallyrepositioned, relative to one another, during the procedure. Also, ifdesired, the guidewire 42 may be fully withdrawn and extracted bypulling the guidewire in a proximal direction such that the distal tipof the guidewire is pulled out of the guidewire entry/re-entry aperture160 and the guidewire 42 is subsequently fully withdrawn out of thebody, leaving only the ultrasound catheter in place.

Another alternative configuration and construction of the distal head 26is shown in the embodiments of FIGS. 5, 5a, 6, 6a and 6b. In suchembodiments, the distal head 26b, 26c is secured to the distal end ofthe catheter body 20b, 20c by way of an annular ring member 150 and aquantity of adhesive ADH. As specifically shown in the views of FIG. 6,6a and 6b, this embodiment of the distal head 26b comprises a distalportion 28b and a reduced diameter proximal portion 30b which isinsertable into the distal end of the lumen 22b of the catheter body20b. The distal portion 28b of the distal head 26b has a grooved detentor annular shoulder 148 formed therein. The proximal portion 30b of thedistal head 26b is inserted into the distal end of the lumen 20b of thecatheter body and may be secured thereto by way of a quantity ofadhesive. An annular ring member 150 is then passed in a proximaldirection over the catheter body 20b and advanced to a point where theannular ring member 150 abuts against shoulder 148. A quantity ofadhesive ADH is then applied to secure the annular ring member 150around the distal tip of the catheter body 20b and the part of thedistal portion 28b of the distal head 26b. The adhesive ADH may betapered or smoothed to form a constant angular transition from thedistal portion 28b of the distal head 26b to the outer surface of thecatheter body 20b as shown. The distal head 26b and annular ring member150 may be formed of any suitable rigid material such as metal orplastic. In embodiments where metal materials are employed, metalbonding or metal welding may be utilized as an alternative to or inaddition to the use of adhesives for bonding the assembly to the distalend of the catheter body 20b. In embodiments wherein the distal head 26band annular ring member 150 are formed of plastic, thermal welding, heatfusing or solvent welding techniques may be used as an alternative or inaddition to the use of adhesives for such purpose.

In the embodiment of the distal head shown in FIGS. 5-6, it ispreferable that the outer diameter of the annular ring member 150 beapproximately the same as the largest outer diameter of the extremedistal portion 28b of the distal head 26b such that a smooth transitionis formed from the distal head 26b to the outer surface of the catheterbody 20b.

Optionally, one or more fluid outflow aperture(s) 50 are formed at ornear the distal end of the catheter body 20 to permit fluid to flow outof a lumen 22 of the catheter 10. The provision of such fluid outflowaperture(s) 50 near the distal end of the catheter 10 facilitatescontinual or intermittent passage of coolant liquid into the proximalend of the lumen 22, distally through the lumen 22, and out of fluidoutflow aperture(s) 50. Preferably, the lumen 22 of the catheter 10 intowhich the fluid outflow aperture(s) communicates will be the same lumenwherein the ultrasound transmission member 24 is located such thatcoolant liquid may be infused into the proximal end of such lumen 22,distally therethrough and out of fluid outflow aperture(s) 50 in amanner that will bathe and cool the body of the ultrasound transmissionmember 24, thereby preventing the ultrasound transmission member 24 fromoverheating during use.

In addition to, or in the alternative to, the optional fluid outflowaperture(s) 50 formed in the catheter body 20, one or more fluid outflowaperture(s) 51 may be formed through the distal head 26 to permit fluidto flow directly out of the distal end of the catheter 10. Inembodiments having a guidewire aperture 40 formed through the distalhead 26, such guidewire aperture may be slightly larger than the outerdiameter of the guidewire 42 to be passed therethrough so as to permitfluid to be infused through the guidewire lumen and to pass out of theguidewire aperture 40, even when a guidewire 42 is extendingtherethrough. Thus, the guidewire aperture 40 may, in some embodiments,preclude the necessity for and/or perform the function of a separatededicated fluid outflow aperture 51 extending through the distal head26.

Optionally, one or more separate lumens having separate outflowapertures formed at or near the distal tip of the catheter may be formedfor infusion of oxygenated perfusate, medicaments or other fluids intothe blood vessel or other anatomical structure in which the catheter ispositioned.

Various types and designs of proximal end connector apparatus 12 may bepositioned on the proximal end of the catheter body to facilitateoperative connection of the ultrasound transmission member 24 to anultrasound transducer 14 and ultrasound generation device 16. Examplesof embodiments of such proximal end connector apparatus 12 are shown inFIGS. 7-10. FIG. 7 shows a relatively simple proximal end connectorapparatus 12a configured for use in connection with catheters which donot incorporate internal guidewire passage lumens. FIG. 8 shows a morecomplex proximal end connector 12b configured for use in connection withcatheters having internal guidewire passage lumens.

The embodiment of the proximal end connector 12a shown in FIG. 7comprises a rear portion 92 and a mid-portion 90. A gripping member 96formed on the proximal end of the mid-portion 90 operates to attach theproximal end connector 12a to the proximal end of the catheter 20. Themid-portion 90 comprises an elongate tubular body 80 having a tubularfluid infusion sidearm 82 extending outwardly therefrom to permitinfusion of coolant fluid or other liquid into the inner lumen 81 of theproximal end connector 12a.

The more complex embodiment of the proximal end connector 12b shown inFIG. 8 comprises the same rear portion 92 and mid-portion 90 as thesimpler embodiment 12a shown in FIG. 7. However, the more complexembodiment 12b of FIG. 8 further comprises a frontal portion 88 which isconfigured and constructed to facilitate insertion and/or extraction ofa guidewire 42 through a lumen or passageway formed internally withinthe catheter 20.

In both embodiments shown, the proximal end connector apparatus 12comprises an elongate rigid body 80 having a hollow bore 81 extendinglongitudinally therethrough. In the embodiment shown, the elongate bodyof the proximal end connector 12 is actually constructed of a frontalportion 88, a mid-portion 90 and a rear portion 92. The frontal portion88 of the elongate body 80 is firmly connected to the proximal end ofthe catheter body 20 by way of a threaded gripping member 94. A sleeve21 having an annular flange 23 formed on the proximal end thereof ispositioned on the proximal end of the catheter body 20 to engagegripping member 94 as shown. The proximal end of the frontal portion 88is connected to the distal end of the mid-portion 90 of the elongatebody 80 by way of a second gripping member 96. Accordingly, tofacilitate such construction, threads 98, 100 are formed on the oppositeends of the frontal portion 88 of the elongate body 80.

Threads 102 are also formed on the proximal end of the mid-portion 90 ofthe elongate body 80 such that the mid-portion 90 may be threadablymounted within a correspondingly threaded bore formed in the distal endof the rear portion 92 of the elongate body 80. An O-ring 104 ispositioned at the bottom of the threaded bore formed in the distal endof the rear portion 92 such that, when the rear portion 92 is tightenedover the threads 102 of the mid-portion 90, the proximal end 108 of themid-portion 90 will abut against and compress O-ring 104 against ledge105, thereby causing O-ring 104 to exert inward pressure against tube110. Tube 110 extends longitudinally through the hollow bore 81 withinthe rear portion 92 of the proximal connector apparatus 12. Theultrasound transmission member 24 or wave guide extends longitudinallythrough the entire catheter body 20 and through the proximal endconnector 12. The ultrasound transmission member 24 or wave guide isinserted into and engaged by threaded proximal connector 112. Threadedproximal connector 112 is positioned within a cylindrical recess 114formed in the proximal end of the proximal connector apparatus 12. Asuitable ultrasound transducer 14 may be screwed onto and threadablyconnected to the threaded proximal connector 112 to accomplish passageof ultrasonic energy through the ultrasound transmission member 24 in adistal direction to the distal head 26 of the device.

The extreme proximal end of the proximal connector 12 is provided with asonic connector assembly or apparatus configured to effect operativeattachment of the proximal end of the ultrasound transmission member 24to the horn of an ultrasound transducer 14. The sonic connector assemblyor apparatus is preferably configured and constructed to permit passageof ultrasound energy through the ultrasound transmission member or waveguide 24 with minimal lateral side-to-side movement of the ultrasoundtransmission member 24 while, at the same time, permitting unrestrictedlongitudinal forward/backward vibration or movement of the ultrasoundtransmission member 24.

In one embodiment of the sonic connector shown in FIG. 10, a distalportion of the body of the threaded proximal connector 112 is configuredto receive therein a compressible gripping ferrule 116. Compressiblegripping ferrule 116 has a small central aperture formed therethroughthrough which the ultrasound transmission member 24 passes, as shown. Afrontal member 118 is threadably tightened within the frontal portion ofthe body of proximal connector member 112 so as to compress grippingferrule 116, thereby causing gripping ferrule 116 to firmly grip andhold the ultrasound transmission member 24 in place within the body ofthe proximal connector member 112. The proximal connector member 112 maythen be compressed or crimped inwardly so as to be additionally crimpconnected or crimp fit to the proximal end of the ultrasoundtransmission member 24, thereby providing further gripping andattachment of the sonic connector assembly to the proximal end of theultrasound transmission member. A series of threads are formed on theouter surface of the proximal connector member 112 to permit the distalend of an ultrasound transducer horn to be threadably screwed onto andreleasably attached to the sonic connector assembly. Thus, the frontalmember 118, gripping ferrule 116, and proximal connector member 112combine to form a sonic connector assembly to which the horn of anultrasound transducer may be attached and through which the ultrasonicenergy may be transmitted into the ultrasound transmission member, withthe gripping ferrule 116 acting to dampen transverse movement of theultrasound transmission member 24.

In a second embodiment of the sonic connector, which is shown in FIGS.11 and 12, a frontal member 218 is positionable on the ultrasoundtransmission member 24, and has a stem 220 with threads 222 providedthereon for threadable engagement with threads 221 provided in anopening of a proximal connector 212. A plurality of compressible plugs224 are configured to fit within the opening of the proximal connector212 perpendicular to the axis of the ultrasound transmission member 24.In the preferred embodiment, four compressible plugs 224 are provided,but it will be appreciated by those skilled in the art that any numberof compressible plugs 224 may be distributed about the circumference ofthe ultrasound transmission member 24. The proximal connector 212 isalso positionable on the ultrasound transmission member 24 and also hasa stem 214 with threads 216 provided thereon for threadable engagementwith threads 217 provided on a cavity 226 of a horn 228 of theultrasound transducer 14. Again, a plurality of compressible plugs 224are configured to fit within the cavity 226 of the ultrasound transducerhorn 228 perpendicular to the axis of the ultrasound transmission member24. The proximal-most end of the ultrasound transmission member 24terminates at the promixal-most end of the stem 214 within the cavity226. The stem 214 and the ultrasound transmission member 24 may becrimped as shown at 230 to provide a more stable connection between thesonic connector assembly and the ultrasound transmission member 24. Thefrontal member 218 and the proximal connector 212 are preferably madefrom stainless steel.

The compressible plugs 224 are preferably disposed along the threads216, 217, 221 and 222 so that when the frontal member 218 is threadablyscrewed onto the proximal connector 212 and the proximal connector 212is in turn threadably screwed onto the ultrasound transducer horn 228,the threads 216, 217, 221 and 222 exert an inward force against theplugs 224 provided thereat, thereby forcing the plugs 224 against theultrasound transmission member 24 to provide a firm grip to minimizetransverse movement of the ultrasound transmission member 24. Thecompressible plugs 224 are preferably made from any compliant materialsuch as plastic, nylon, teflon, ABS, polypropylene, polyolefins, naturaland synthetic rubbers and ethylene vinyl acetate (EVA). The complianceof the plugs 224 also secures the threaded connection between thefrontal member 218 and the proximal connector 212 so that thisconnection does not become loosened, which would otherwise cause theultrasound transmission member 24 to become disengaged. It will beappreciated by those skilled in the art that the plugs 224 may beprovided at the threads 221 and 222 only, or at the threads 216 and 217only, at both sets of threads 216 and 217 and 221 and 222, or elsewherealong the stems 214 and 220.

In a third embodiment of the sonic connector, which is shown in FIG. 13,a gripping ferrule 116 is positioned between the threaded connectionbetween the frontal member 218 and the proximal connector 212. Aplurality of compressible plugs 224 are positioned between the threadedconnection between the proximal connector 212 and the transducer horn228. Thus, the embodiment of FIG. 13 utilizes both the gripping ferruleand the compressible plugs to achieve the damping of transverse movementby the ultrasound transmission member 24, and to secure the ultrasoundtransmission member 24 to the sonic connector.

Alternatively, a polymeric coating may be applied to the threads 216,217, 221 and 222. The coating creates friction which functions to securethe threaded connections and prevent the threaded connections frombecoming loose. This polymeric coating may be made by PVC dispersionsusing a solvent release approach, or by thermal application of variousthermoplastics such as polyethelene, EVA, and nylon, among others. Itwill be appreciated by those skilled in the art that the polymericcoating may be applied independent of the compressible plugs 224, or inconjunction with the compressible plugs 224. The polymeric coating mayalso be applied to the threaded regions of the first embodiment of thesonic connector assembly described in connection with FIG. 10.Alternatively, the polymeric coating may also be applied between thethreaded connection between the proximal connector 212 and thetransducer horn 228, with compressible plugs 224 or a gripping ferrule116 provided between the threaded connection between the frontal member218 and the proximal connector 212. For example, the embodiment of FIG.14 has a polymeric coating 250 provided between the transducer horn 228and the proximal connector 212, with compressible plugs 224 providedbetween the frontal member 218 and the proximal connector 212.Similarly, the embodiment of FIG. 15 has a polymeric coating 250provided between the transducer horn 228 and the proximal connector 212,with a gripping ferrule 116 provided between the frontal member 218 andthe proximal connector 212.

The elongate tube 110 which extends through the rear portion 92 of theproximal connector apparatus 12 is specifically sized such that thelumen 120 of the tube 110 is large enough to permit the ultrasoundtransmission member 142 to pass therethrough with a small amount ofspace remaining between the outer surface of the ultrasound transmissionmember 24 and the inner luminal surface of the tube 110.

A fluid inlet sidearm 82 is formed on the rigid body 80 of the proximalend connector apparatus 12. Such fluid inlet sidearm 82 has a hollowbore 122 which extends therethrough and is in fluid communication withthe longitudinal bore 81 of the proximal end connector 12.

Thus, pressurized fluid, such as a coolant liquid, may be infusedthrough sidearm 82, through bore 81 and through the lumen 22 of thecatheter body 20 to a point where such liquid flows out of fluid outflowapertures 50. The temperature and flow rate of such coolant liquid maybe specifically controlled to maintain the temperature of the ultrasoundtransmission member 24 at a desired temperature within its optimalworking range. In particular, in embodiments of the invention whereinthe ultrasound transmission member 24 is formed of a metal alloy whichexhibits optimal physical properties (e.g. super elasticity) within aspecific range of temperatures, the temperature and flow rate of coolantliquid infused through fluid infusion sidearm 82 may be specificallycontrolled to maintain the temperature of the ultrasound transmissionmember within the range of temperatures at which it demonstrates itsmost desirable physical properties. For example, in embodiments of theinvention wherein the ultrasound transmission member 24 is formed of ashape memory alloy which exhibits super elasticity when in itsmartensite state, but which loses super elasticity as it transitions toan austenite state, it will be desirable to adjust the temperature andflow rate of the coolant liquid infused through fluid infusion sidearm82 so as to maintain the shape memory alloy of the ultrasoundtransmission member 24 within a temperature range at which the alloywill remain in its martensite state and will not transition to anaustenite state. The temperature at which such shape memory alloystransition from a martensite state to an austenite state is known as the"martensite transition temperature" (M_(s)) of the material. Thus, inthese embodiments, the fluid infused through sidearm 82 will be at suchtemperature, and will be infused at such rate, as to maintain the shapememory alloy of the ultrasound transmission member 24 below itsmartensite transition temperature (M_(s)).

A guidewire insertion sidearm 84 may also be formed on the elongate body80 of the proximal end connector apparatus 12. Such guidewire passagesidearm 84 has a hollow lumen 130 extending therethrough andcommunicating with the longitudinal bore 81 of the proximal endconnector 12. A guidewire gripping/sealing apparatus 132 may be mountedon guidewire passage sidearm 84 to grasp and hold the guidewire 42 infixed longitudinal position relative to the catheter 10 and to provide aseal to prevent backflow of blood through the catheter 10. Examples ofguidewire gripping/sealing apparatus 132 which may be utilized in thisapplication include those which are which are available commercially asProduct Nos. 1905017A and 1905014A from Medical DisposablesInternational, West Conshocken, Pa. Such commercially availableguidewire gripping/valving apparatus 132 may be modified by inserting asegment of plastic tubing 134 into the bore of such device to permitsuch device 132 to grip and seal against a guidewire 42 which is smallerin diameter than the existing diameter of the seal provided in suchcommercially available MDI sealing/valving apparatus 132. Othersealing/valving apparatus may also be employed.

Additionally, in the embodiment shown in FIG. 9, an angled guidewirediverter tube 140 is positioned within the bore 130 of the guidewirepassage sidearm 84 and a portion of the longitudinal bore 81 of the body80 of the proximal end connector apparatus 12. Such guidewire divertertube 140 comprises an obtuse angular bend B having an aperture 142formed at the outer apex of such angular bend B. The aperture 142 issufficiently large to permit the ultrasound transmission member 24 topass longitudinally therethrough without damping or interference fromthe body of the tube 140. Also, the aperture 142 is sufficiently largeto allow irrigation/coolant liquid to flow therethrough when theultrasound transmission member 24 is positioned within the aperture 142.

The guidewire diverter tube 140 is configured and constructed such that,as the proximal end of guidewire 42 is advanced in a proximal directionthrough the longitudinal bore 81 of the elongate body 80 of the proximalend connector 12, it will impinge against the wall of guidewire divertertube 140 and will thus be diverted outwardly through the guidewirepassage sidearm 84.

Although the invention has been described herein with specific referenceto presently preferred embodiments thereof, it will be appreciated bythose skilled in the art that various additions, modifications,deletions and alterations may be made to such preferred embodimentswithout departing from the spirit and scope of the invention.Accordingly, it is intended that all reasonably foreseeable additions,deletions, alterations and modifications be included within the scope ofthe invention as defined in the following claims.

What is claimed is:
 1. An ultrasonic catheter for removing obstructionsfrom tubular anatomical structures such as blood vessels, saidultrasonic catheter comprising:an elongated flexible catheter bodyhaving a proximal end, a distal end and at least one lumen extendinglongitudinally therethrough; an ultrasound transmission member extendinglongitudinally through said lumen of said catheter, said ultrasoundtransmission member having a proximal end connectable to a separateultrasound generating device and a distal end terminating adjacent thedistal end of said catheter body; a sonic connector assembly beingpositioned on the proximal end of said ultrasound transmission member tofacilitate connection of said ultrasound transmission member to aseparate ultrasound transducer, said sonic connector assemblycomprising;(i) a frontal member positionable on said ultrasoundtransmission member and having a threaded region formed thereon; (ii) aproximal member positionable on said ultrasound transmission member andhaving a first threaded region formed thereon and rotatably engageablewith the threaded region of said frontal member component, said proximalmember further including a stem provided with a series of threadsthereby forming a second threaded region, said stem configured toreceive a correspondingly threaded bore of the horn of a separateultrasound transducer; (iii) first means positionable between saidproximal member and said bore of said transducer horn; (iv) second meanspositionable between said frontal member and said proximal member; (v)said first means being sized and configured relative to said proximalmember and said transducer horn, and said second means being sized,configured and constructed relative to said frontal member and saidproximal member, such that said first and second means will becomeinwardly compressed against said ultrasound transmission member whensaid frontal member component and said proximal member are connected toone another and when said proximal member and said bore of saidtransducer horn are connected to one another by rotatable threadedconnection.
 2. The ultrasonic catheter of claim 1 wherein said sonicconnector assembly is positioned on the extreme proximal end of saidultrasound transmission member with the proximal end of said ultrasoundtransmission member being coterminous with the proximal-most extent ofsaid proximal member of said sonic connector assembly.
 3. The ultrasoniccatheter of claim 1 wherein said proximal member is further affixed tosaid ultrasound transmission member to accomplish additional crimpconnection of said sonic connector assembly to said ultrasoundtransmission member.
 4. The ultrasonic catheter of claim 1 wherein saidthreaded region of said frontal member, said first threaded region ofsaid proximal member, said second threaded region of said proximalmember, and said threaded bore of said transducer horn are coated with apolymeric coating.
 5. The ultrasonic catheter of claim 1 wherein saidfirst means comprises a compressible gripping ferrule.
 6. The ultrasoniccatheter of claim 5 wherein said second means comprises a plurality ofcompressible plugs.
 7. The ultrasonic catheter of claim 1 wherein saidfirst means comprises a plurality of compressible plugs.
 8. Theultrasonic catheter of claim 7 wherein said second means comprises aplurality of compressible plugs.
 9. The ultrasonic catheter of claim 5wherein said second means comprises a gripping ferrule.
 10. Anultrasonic catheter for removing obstructions from tubular anatomicalstructures such as blood vessels, said ultrasonic catheter comprising:anelongated flexible catheter body having a proximal end, a distal end andat least one lumen extending longitudinally therethrough; an ultrasoundtransmission member extending longitudinally through said lumen of saidcatheter, said ultrasound transmission member having a proximal endconnectable to a separate ultrasound generating device and a distal endterminating adjacent the distal end of said catheter body; a sonicconnector assembly being positioned on the proximal end of saidultrasound transmission member to facilitate connection of saidultrasound transmission member to a separate ultrasound transducer, saidsonic connector assembly comprising;(i) a frontal member positionable onsaid ultrasound transmission member and having a threaded region formedthereon; (ii) a proximal member positionable on said ultrasoundtransmission member and having a first threaded region formed thereonand rotatably engageable with the threaded region of said frontal membercomponent with a said proximal member further including a stem providedwith a series of threads thereby forming a second threaded region, saidstem configured to receive a correspondingly threaded bore of the hornof a separate ultrasound transducer; (iii) a plurality of compressibleplugs positionable between said proximal member and said bore of saidtransducer horn; (iv) a compressible gripping ferrule positionablebetween said frontal member and said proximal member; (v) said pluralityof compressible plugs being sized and configured relative to saidproximal member and said transducer horn, and said gripping ferrulebeing sized, configured and constructed relative to said frontal memberand said proximal member, such that said gripping ferrule and saidplurality of plugs will become inwardly compressed against saidultrasound transmission member when said frontal member component andsaid proximal member are connected to one another and when said proximalmember and said bore of said transducer horn are connected to oneanother by rotatable threaded connection.
 11. The ultrasonic catheter ofclaim 10 wherein said sonic connector assembly is positioned on theextreme proximal end of said ultrasound transmission member with theproximal end of said ultrasound transmission member being coterminouswith the proximal-most extent of said proximal member of said sonicconnector assembly.
 12. The ultrasonic catheter of claim 10 wherein saidproximal member is further affixed to said ultrasound transmissionmember to accomplish additional crimp connection of said sonic connectorassembly to said ultrasound transmission member.
 13. The ultrasoniccatheter of claim 10 wherein said plurality of plugs are positioned onsaid second threaded region of said proximal member.
 14. The ultrasoniccatheter of claim 10 wherein said threaded region of said frontalmember, said first threaded region of said proximal member, said secondthreaded region of said proximal member, and said threaded bore of saidtransducer horn are coated with a polymeric coating.